Getting stuck is a normal part of a product developer's life, here are 9 ways to fix that!
“The illiterate of the 21st century will not be those who cannot read and write, but those who cannot learn, unlearn, and relearn.” – Alvin Toffler
An insufficient or incomplete design input specification (DIS) can lead to a host of problems and create a big mess. A design input specification is a design control requirement for medical devices seeking regulatory approval. According to the FDA, your DIS must be testable, measurable, unambiguous, and traceable. Ambiguity leads to poor design inputs. … Continue reading “Your Design Input Specification is important beyond regulatory compliance”
Creating your design input specification (DIS) should be the first stage of any product design process. It is a vital tool your Design Team will use as the framework for the design and development of your medical device, and to also comply with regulatory requirements. Wait! Just what is DIS? In the simplest terms, your… Continue reading How to turn User Needs into Design Specifications (with tables)
A design input specification (DIS) plays a critical role in any product design process. The product DIS contains all the characteristics of a device that are used as a basis for product design. The level of detail that your design inputs cover can be the deciding factor that makes or breaks a smooth run to… Continue reading KICKSTART YOUR DIS: 6 Approaches to Generate Design Inputs